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(2S)-2-[[(1S)-1-Carboxy-5-[[(2S)-2-[[4-[[[(2S)-4-Carboxy-2-[[(2S)-4-Carboxy-2-[(6-(18F)Fluoranylpyridine-3-Carbonyl)Amino]Butanoyl]Amino]Butanoyl]Amino]Methyl]Benzoyl]Amino]-3-Naphthalen-2-Ylpropanoyl]Amino]Pentyl]Carbamoylamino]Pentanedioic Acid

This article discusses two clinical trials investigating the use of [18F]PSMA-1007, a radioactive tracer, in PET/CT and PET/MRI imaging for diagnosing and staging prostate cancer. These studies aim to improve the accuracy of detecting clinically significant prostate cancer and assessing the spread of the disease in high-risk patients. The trials explore the potential of this advanced imaging technique to provide more precise information for patient care and treatment planning.

Table of Contents

What is [18F]PSMA-1007?

[18F]PSMA-1007 is a diagnostic tool used in the detection of prostate cancer. It’s a type of radioactive tracer that helps doctors see potential cancer cells more clearly during imaging tests. The full chemical name of this compound is (2S)-2-[[(1S)-1-carboxy-5-[[(2S)-2-[[4-[[[(2S)-4-carboxy-2-[[(2S)-4-carboxy-2-[(6-(18F)fluoranylpyridine-3-carbonyl)amino]butanoyl]amino]butanoyl]amino]methyl]benzoyl]amino]-3-naphthalen-2-ylpropanoyl]amino]pentyl]carbamoylamino]pentanedioic acid. It’s also known by several other names, including F-18-PSMA-1007, PSMA-1007 (18F), 18F-PSMA-1007, and PSMA-1007 F-18.[1]

How It Works

[18F]PSMA-1007 works by targeting a specific protein called Prostate-Specific Membrane Antigen (PSMA). This protein is found in high amounts on the surface of prostate cancer cells. When injected into the body, [18F]PSMA-1007 attaches to these PSMA proteins. The radioactive element (18F) in the compound then allows special cameras to detect where the tracer has accumulated, potentially revealing the location of prostate cancer cells.[1]

Uses in Prostate Cancer Diagnosis

[18F]PSMA-1007 is primarily used in combination with imaging techniques like PET/CT (Positron Emission Tomography/Computed Tomography) or PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging). These scans help doctors to:

  • Detect prostate cancer in its early stages
  • Determine if cancer has spread to other parts of the body
  • Monitor how well treatment is working
  • Check for any recurrence of cancer after treatment

It’s particularly useful in detecting high-risk or very-high-risk prostate cancer, which are more aggressive forms of the disease.[1]

How It’s Administered

[18F]PSMA-1007 is given as an injection into a vein (intravenous use). The maximum dose is typically around 450 MBq (megabecquerels, a unit of radioactivity). After the injection, patients undergo imaging scans that can last for about 30-60 minutes.[1]

Ongoing Research

Several clinical trials are currently underway to further evaluate the effectiveness of [18F]PSMA-1007. These studies aim to:

  1. Assess the diagnostic performance of [18F]PSMA-1007 PET/CT imaging in patients with newly-diagnosed high-risk or very-high-risk prostate cancer.[1]
  2. Determine the accuracy of fully hybrid 18F-PSMA PET/MRI as a one-stop approach for diagnosing clinically significant prostate cancer.[2]

These studies aim to provide more evidence on how well [18F]PSMA-1007 can detect prostate cancer, especially in its early stages or when it has spread to nearby lymph nodes.

Patient Eligibility

While [18F]PSMA-1007 shows promise, it’s not suitable for everyone. Typical eligibility criteria for patients in clinical trials include:

  • Being 18 years of age or older
  • Having a clinical suspicion of prostate cancer or newly diagnosed high-risk prostate cancer
  • No previous diagnosis or treatment for prostate cancer
  • Ability to undergo all required tests and procedures

Patients with certain conditions, such as severe claustrophobia or those with certain medical implants, may not be eligible for the imaging procedures.[1][2]

Potential Benefits

The use of [18F]PSMA-1007 in prostate cancer diagnosis could potentially offer several benefits:

  • Earlier and more accurate detection of prostate cancer
  • Better identification of cancer spread, which can guide treatment decisions
  • Improved monitoring of treatment effectiveness
  • Reduced need for invasive diagnostic procedures in some cases

However, it’s important to note that while [18F]PSMA-1007 shows promise, more research is needed to fully understand its benefits and limitations in prostate cancer diagnosis and management.[1][2]

Aspect Trial 1 (2023-504026-19-01) Trial 2 (2024-512859-21-00)
Main Objective Assess sensitivity and specificity of [18F]PSMA-1007 PET/CT in detecting pelvic nodal metastases in high-risk prostate cancer Determine diagnostic accuracy of [18F]PSMA-1007 PET/MRI for clinically relevant prostate cancer
Patient Population Newly diagnosed high-risk or very-high-risk prostate cancer Patients with suspected clinically significant prostate cancer
Imaging Technique PET/CT PET/MRI
Primary Endpoint Sensitivity and specificity for detecting pelvic nodal metastases Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values)
Key Inclusion Criteria Age ≥18, newly diagnosed prostate cancer, high-risk features Age ≥18, suspected clinically significant prostate cancer
Key Exclusion Criteria Prior prostate cancer treatment, contraindications to imaging Previous prostate cancer diagnosis, contraindications to MRI or biopsy

FAQ

  • What is [18F]PSMA-1007? [18F]PSMA-1007 is a radioactive tracer used in PET imaging. It binds to a protein called PSMA, which is often found in high levels on prostate cancer cells. This allows doctors to see potential cancer sites more clearly on the scans.
  • What are the main goals of these clinical trials? The trials aim to determine how accurate [18F]PSMA-1007 PET/CT and PET/MRI are in diagnosing clinically significant prostate cancer and detecting its spread to lymph nodes in high-risk patients.
  • Who can participate in these trials? The trials are looking for adult men (18 years or older) with either suspected prostate cancer or newly diagnosed high-risk prostate cancer. Specific eligibility criteria may vary between the two studies.
  • Are there any risks associated with the imaging procedure? The procedure involves exposure to a small amount of radiation from the tracer. Patients will be informed of any potential risks before participating. Some patients may not be eligible if they have certain medical conditions or implants that are not compatible with MRI scans.
  • How might this research benefit prostate cancer patients? If successful, these imaging techniques could provide more accurate diagnosis and staging of prostate cancer. This could lead to better treatment planning and potentially improve outcomes for patients with prostate cancer.

Ongoing Clinical Trials on (2S)-2-[[(1S)-1-Carboxy-5-[[(2S)-2-[[4-[[[(2S)-4-Carboxy-2-[[(2S)-4-Carboxy-2-[(6-(18F)Fluoranylpyridine-3-Carbonyl)Amino]Butanoyl]Amino]Butanoyl]Amino]Methyl]Benzoyl]Amino]-3-Naphthalen-2-Ylpropanoyl]Amino]Pentyl]Carbamoylamino]Pentanedioic Acid

  • Study on the Use of [18F]PSMA-1007 PET/CT Imaging for Detecting Prostate Cancer in Patients with Newly Diagnosed High-Risk or Very-High-Risk Conditions

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Spain

Glossary

  • PET: Positron Emission Tomography, an imaging technique that uses a small amount of radioactive tracer to show how organs and tissues are functioning.
  • CT: Computed Tomography, an X-ray imaging technique that produces detailed cross-sectional images of the body.
  • MRI: Magnetic Resonance Imaging, a technique that uses strong magnetic fields and radio waves to create detailed images of organs and tissues in the body.
  • PSMA: Prostate-Specific Membrane Antigen, a protein found on the surface of prostate cells, often in higher amounts in prostate cancer cells.
  • Prostate cancer: A type of cancer that occurs in the prostate gland, which is part of the male reproductive system.
  • Lymph nodes: Small structures that are part of the body's immune system, which can be sites where cancer spreads.
  • Biopsy: A medical procedure to remove a small sample of tissue or cells from the body to examine it more closely.
  • Staging: The process of determining the extent of cancer in the body, including whether it has spread beyond its original site.
  • High-risk prostate cancer: Prostate cancer that has a higher chance of growing and spreading quickly.
  • Clinically significant prostate cancer: Prostate cancer that is likely to impact a patient's health and quality of life if left untreated.

References

  1. http://clinicaltrials.eu/trial/study-on-the-use-of-18fpsma-1007-pet-ct-imaging-for-detecting-prostate-cancer-in-patients-with-newly-diagnosed-high-risk-or-very-high-risk-conditions/
  2. http://clinicaltrials.eu/trial/study-on-the-use-of-18f-psma-1007-pet-mri-for-diagnosing-significant-prostate-cancer-in-patients-with-suspected-prostate-cancer/